Side branch stenting system using a main vessel constraining side branch access balloon and side branching stent

ABSTRACT

A side branch stenting system using a catheter/stent assembly having a balloon with adjacent globular and cylindrical portions and a stent mounted thereon over the cylindrical portion The stent has finger-like projections mounted over portion of the globular portion of the balloon. At a bifurcation site with another stent in place in the main vessel and having an opening into a side branch, the catheter/stent assembly is placed in the side branch and inflated. The cylindrical portion of the balloon expands the main stent body in the side vessel. The globular portion of the balloon inflates in the main vessel, constraining the main vessel and bending the finger-like projections around the circumference of the opening into the side branch.

CROSS-REFERENCE TO RELATED APPLICATIONS

Not Applicable

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH

Not Applicable

BACKGROUND OF THE INVENTION

Stents and other radially expandable endoprostheses are typicallyimplanted transluminally and enlarged radially after being introducedpercutaneously. Such endoprostheses may be implanted in a variety ofbody lumens or vessels such as within the vascular system, urinarytracts, bile ducts, fallopian tubes, coronary vessels, secondaryvessels, etc. Some may be used to reinforce body vessels and/or toprevent restenosis following angioplasty in the vascular system. Theymay be self-expanding, expanded by an internal radial force, such aswhen mounted on a balloon, or a combination of self-expanding andballoon expandable (hybrid expandable).

Within the vasculature it is not uncommon for stenoses to form at avessel bifurcation. A bifurcation is an area of the vasculature or otherportion of the body where a first component vessel divides into two ormore component vessels. Where a stenotic lesion or lesions form at sucha bifurcation, the lesion(s) can affect one, two or all three of theinvolved vessels.

Many of the devices that have been disclosed for deployment atbifurcations are deployed as a first stent, extending from one componentvessel into a second, crossing the vessel opening (“ostium”) into thethird vessel. After the first stent has been deployed, an opening in thestent side-wall disposed at the ostium can then be enlarged by placing aballoon therethrough and expanding the balloon. This opening enlargementfacilitates fluid flow into or from the third vessel. If needed, asecond stent may also be placed in the third vessel.

In some instances of stent placement at a bifurcation a first stentconfiguration is employed which has a specialized side-branch openingthrough which the opening into the third vessel may be provided. Oftensuch designs include a portion of the first stent which is displacedinto and against the side-wall of the third vessel for a short distancebeyond the ostium.

BRIEF SUMMARY OF THE INVENTION

The invention of the present application pertains, in various aspects,to methods of deploying stent assemblies at bifurcations, tocatheter/stent assemblies and to two-stent assemblies useful forplacement at bifurcation sites.

In one aspect the invention pertains to a method for deploying a stentassembly at a bifurcation comprising first, second and third vessels, amain channel between the first and second vessels and an ostium into thethird vessel, the method comprising:

deploying a first stent in said main-channel between the first andsecond vessels to engage the vessel walls thereof and cross the ostiumwith a side branch projection extending through the ostium into thethird vessel,

providing a second stent which overlaps and extends beyond the sidebranch projection of the first stent in the third vessel, the secondstent having a plurality of finger-like projections extending into themain-channel,

expanding the second stent to engage the vessel wall of the thirdvessel, and

bending said finger-like projections of the second stent around theperimeter of the ostium to engage the first stent in the main channeland provide for a linked assembly of the two stents.

In another aspect the present invention is directed to an assemblycomprising:

a catheter shaft,

a balloon mounted on the catheter shaft, the balloon having

-   -   an inflatable first chamber having a globular configuration with        a maximum perpendicular dimension (D1) taken in a plane        perpendicular to the longitudinal axis of the balloon and an        axial length (D3) which is not more than about 20% greater than        the maximum perpendicular dimension (D1), and    -   an independently inflatable adjacent second chamber having a        generally cylindrical body portion which has a diameter (D2)        which is less than the first chamber diameter axial length (D3).    -   a stent mounted on the catheter, the stent having a tubular body        which includes a main body portion, and a plurality of        finger-like projections, the stent mounted over the balloon such        that the finger like projections are disposed over a portion of        the first chamber and the main body portion is disposed over the        second chamber.

In another aspect the present invention is directed to an assemblycomprising:

a first stent having a longitudinal axis, a tubular wall and a sidebranch projection extending at an angle to the longitudinal axis from aportion of the tubular wall, and

a catheter assembly extending through the side branch projection of thefirst stent, the catheter assembly comprising:

-   -   a catheter shaft,    -   a balloon mounted on the catheter shaft, the balloon having two        adjacent independently inflatable chambers,        -   a first of said chambers having a globular configuration            when inflated, and a second of said chambers disposed            distally of the first chamber, the second chamber having a            generally cylindrical configuration, and    -   a second stent, the second stent having a tubular body which        includes a main body portion, and, a plurality of finger-like        projections the second stent mounted over the balloon such that        the finger like projections are disposed over a portion of the        first chamber and the main body portion is disposed over the        second chamber.

In still another aspect the invention pertains to a two-stent assemblycomprising:

a first stent having a tubular wall with a longitudinal axis, a sidebranch projection extending at an angle to the longitudinal axis from aportion of the tubular wall, with an side branch opening in the tubularwall into the side branch projection, and

a second stent having a longitudinal axis extending through andoverlapping the side branch projection of the first stent, the secondstent having a plurality of finger-like projections at one end bentaround the side branch opening to engage the tubular wall of the firststent.

These and other aspects of the invention are described further in thedescription, figures and claims which follow.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)

FIG. 1 is a schematic representation of a vessel bifurcation with afirst stent deployed in a main channel across the bifurcation and havinga side projection extending into the branch vessel.

FIG. 2 is a view as in FIG. 1 with a balloon catheter and stent assemblyextending through the side projection of the first stent for placementof a second stent.

FIG. 3 is a view as in FIG. 2, showing a first inflation stage of theballoon catheter that carries the second stent.

FIG. 4 is view as in FIG. 3 with the balloon fully inflated.

FIG. 5 is a side view of the distal end of a balloon catheter which maybe employed in the invention, with the balloon inflated.

FIG. 6 is a side view of an illustrative first stent which may beemployed in the invention.

FIG. 7 is a side view of a view of the distal end of a balloon catheterwhich may be employed in the invention, with the balloon deflated and asecond stent mounted thereon.

FIG. 8 is a side view of one configuration of a second stent accordingto the invention.

FIG. 9 is a side view of an alternate configuration of a second stentaccording to the invention.

DETAILED DESCRIPTION OF THE INVENTION

While this invention may be embodied in many different forms, there aredescribed in detail herein specific embodiments of the invention. Thisdescription is an exemplification of the principles of the invention andis not intended to limit the invention to the particular embodimentsillustrated.

All published documents, including all US patent documents, mentionedanywhere in this application are hereby expressly incorporated herein byreference in their entirety. Any copending patent applications,mentioned anywhere in this application are also hereby expresslyincorporated herein by reference in their entirety.

For the purposes of this disclosure, like reference numerals in thefigures shall be taken as referring to like features unless otherwiseindicated.

FIG. 1 schematically depicts a bifurcated blood vessel having a firststent 14 disposed therein. Components of the bifurcation are firstvessel 6, second vessel 8 and third vessel 10. In this particularembodiment the first and second vessels taken together form a mainchannel with the third vessel forming a branch vessel having an opening11 to the main channel, but there is no particular requirement that thebifurcation form distinct main and side channels. At one side of theopening 11 (the ostium), between the vessels 8 and 10, is a carinaregion 12. A stent 14 is deployed at the bifurcation, extending from thefirst vessel into second vessel and crossing the ostium. Stent 14includes a side branch projection 16 which extends into the third vessel10.

Referring to FIG. 6 there is depicted an exemplary main-channel stent14, in expanded configuration, which may be employed according to theinvention. The stent 14 includes main channel support bands 15,connectors 17 between the support bands, a side channel projection 16and a frame 18 which provides an interface between the side channelprojection and the main channel support bands. Deployment of such stentsmay be accomplished in a known manner. Alternatively, as described inthe patent application of the same inventor, U.S. application Ser. No.11/592,365, filed Nov. 3, 2006, titled “Main Vessel Constraining SideBranch Access Balloon,” incorporated herein by reference in itsentirety, a multi-chamber balloon which is the same or similar to thatof balloon 25, described below, may be used to extend the side channelprojection 16 of stent 14 into the third vessel 10.

A first stent 14 is deployed in across an ostium in a main channel andexpanded to support the main channel. The first stent has a side channelprojection 16 which can be extended into the side vessel 10 afterplacement of the stent in the first vessel. For purposes of the presentinvention partial projection of the side channel projection 16 may becarried out, as shown in FIG. 1, before moving to the step illustratedin FIG. 2. This may be done in a known manner. In other embodiments,projection of the side branch portion may be complete, i.e., with theportion 16 expanded to and fully engaged with the side vessel, beforemoving to the next step. In still other embodiments projection of theside channel portion might be deferred until balloon expansion in thestep illustrated in FIG. 3, if the portion of the first stent whichforms the side channel projection has an opening which is configured ina way that allows passage of the catheter carrying the second stentdirectly therethrough.

Referring to FIG. 2, a catheter 20 having a second stent 22 mountedthereon over an inflatable balloon 25 is passed into the stent 14 andthrough the side channel projection 16, or through an opening that isenlargable and projectable to form such a side channel projection.Second stent 22 includes finger-like proximal end projections 24 thatremain in the main channel.

The fully inflated configuration of an exemplary configuration for aballoon 25 is depicted in FIG. 5. Balloon 25, has two chambers 28, 30.The proximal balloon portion 28 has a globular shape, for instance itmay be spherical or generally spherical. The distal balloon portion 30has a generally cylindrical configuration. The chambers 28 and 30 areindependently inflatable. Separate lumens, not shown, and a lumencontrol, also not shown, are provided to the respective chambers so thatsequenced inflation of the chambers 28 and 30 may be provided. In someembodiments it may also be desirable that the chambers 28 and 30 beconcurrently inflatable at different pressures. This can be accomplishedusing combination of valves and pressure controls which allows for onechamber to be inflated and isolated at pressure before the other chamberis inflated.

In at least some embodiments the portions 28 and 30 are sized relativeto each other such that a maximum perpendicular dimension D1 taken in aplane perpendicular to the axis of the balloon, is larger than thedimension D2, corresponding to the diameter of the cylindrical portion30, and larger than the major dimension of the ostium of the branchopening across which the stent is to be placed. D3, the axial length ofthe globular portion 28, may be somewhat less than D1 due to truncationat one or both ends of the globular portion 28 along the balloon axis,but is suitably at least slightly larger than the diameter of the firststent after vessel placement and also larger than the diameter D2 of thecylindrical portion 30.

Truncation of the axial length of portion 28 occurs at least on itsdistal end at the junction with cylindrical portion 30. The balloonportion 28 at its proximal end is preferably, but not necessarily,mounted on the catheter in everted fashion to facilitate the angularbending of the catheter into the side arm, and in some cases this mayproduce some truncation of the axial length D2 of portion 28 relative tothe dimension D1.

In some embodiments the junction 29 between balloon portions 28 and 30is necked so that the dimension D4 is less than D2. If the frame 18 ofstent 14 has major and minor dimensions when deployed suitably D4 is atleast smaller than the major dimension of the frame 18. In someembodiments D4 is also less than the minor dimension. This sizingassures that the globular portion, when inflated in the main channel,will engage and support the frame 18.

The catheter 20 may have an inner shaft 39 that extends through bothballoon portions to provide a guide wire lumen. In an alternativeembodiment the catheter 20 upon which the balloon of the invention ismounted may be a fixed wire catheter or other type of catheter that iscapable of being advanced through the vasculature or other bodylumen(s). Radiopaque markers 40 may be provided to facilitatefluoroscopic location of the catheter in processing. In some embodimentssuch markers may be provided along the inner shaft within the globularportion 28 of the balloon 25, for instance near the longitudinal centerthereof, and within the cylindrical portion, for instance near the endsof the cylindrical portion 30. Other locations may be marked in additionor in alternative to these locations.

Referring to FIG. 7, a catheter assembly for placement of the secondstent 22 is shown. The second stent 22 is mounted on the catheterassembly over the deflated balloon 25. Stent 22 has a main body portion34, at least the substantial majority of which is mounted over thedistal cylindrical balloon portion 30 and finger-like projections 24 atthe proximal end which are mounted over a distal portion of globularportion 28 of the balloon. A proximal region 35 of globular balloonportion 30 is uncovered by the stent. In some embodiments the uncoveredregion 35 is about 50% or more of the longitudinal length of portion 30,for instance about 60 to about 85% of the length of portion 30 is notcovered by the stent.

In a first inflation stage of the inventive method, depictedschematically in FIG. 3, the cylindrical portion 30 of the balloon 26 isinflated expanding the main body of the side branch stent 24 in thevessel 10. If the side projection 16 of the first stent 14 has not beenfully engaged with the vessel 10, this step will also further enlargethe side projection so that it is fully engaged with the vessel 10. Atthis stage the finger-like projections 24 of the second stent 22 remainextended within the main channel.

Then, in a second inflation stage, depicted in FIG. 4, the globularportion 28 of the balloon 25 is also inflated, filling the main channelin a region larger than the ostium between the main and side channels sothat the ostium is supported, including in the carina region 12, whilethe finger-like projections 24 of stent 22 are bent against the wall ofstent 14 around the perimeter of the frame 18. Overlap of thefinger-like projections from the side branch stent 24 in the mainchannel, coupled with the use of a side branch projection of the stent14 assures a secure deployment of both stents.

Except for the finger-like projections on the proximally mounted end,the second stent employed in the inventive process may have aconventional configuration. Exemplary stent configurations which may bemodified to include such finger-like projections include those sold byBoston Scientific Corporation under the trademarks Liberté, TAXUSExpress2, and Barracuda.

FIGS. 8 and 9 are illustrative of second stents 22 which may be employedin the invention. In both figures the main body portion 34 includesannular support bands 32 and connectors 38. In FIG. 8 the finger-likeportions at the end extend straight relative to the longitudinal axis ofthe stent. In FIG. 9 the finger-like portions extend at an anglerelative to the longitudinal axis.

Referring again to FIG. 5, exemplary balloon dimensions may be taken ata nominal inflation pressure, suitably about 2 to about 6 atm, forinstance 4 atm. Without limitation, D2 may be from about 1 mm to about20 mm. In some embodiments D1 may be for instance from 10-50% largerthan D2. D4 may be for instance 2-20% less than D2.

In the embodiment of the balloon 25 shown in the figures the globularportion 28 of the balloon 25 is substantially spherical other than thetruncation along the axial axis which renders the axial length D3 lessthan the maximum perpendicular dimension D1. In other embodiments theoverall shape of the balloon may be more ellipsoid or ovoid thanspherical. In such embodiments, however, the axial length suitably willnot more than about 20% greater than the maximum perpendicular dimensionD1 and more suitably will be equal or less than the D1 dimension. Alsosuitably the D3 dimension will be larger than the diameter (D2) of thecylindrical portion of such balloons. Likewise, in use, a balloon sizewill be selected in which the axial length D3 of the globular portion isequal to or greater than the diameter of the stent 14 as deployed. Insome instances the axial length D3 is about 100-150% of the diameter ofthe first stent diameter in the main channel, for instance about100-120%. This assures that when inflated the portion 28 will fill themain channel and push against the frame 18 around the circumferencethereof so that the tubular main channel wall is not deflected inward aspart of the deployment of the second stent.

The balloon 25 may be made of known balloon polymer materials. Examplesof known materials include polyesters, polyolefins, nylons,polyurethanes and various block copolymers. Exemplary documentsdescribing suitable materials which may be employed in the inventioninclude: U.S. Pat. No. 4,490,421 Levy, and U.S. Pat. No. 5,264,260,Saab, which describe PET balloons; U.S. Pat. No. 4,906,244, Pinchuk etal, and U.S. Pat. No. 5,328,468, Kaneko, which describe polyamideballoons; U.S. Pat. No. 4,950,239, Gahara, and U.S. Pat. No. 5,500,180,Anderson et al which describe balloons made from polyurethanes; U.S.Pat. No. 5,556,383, Wang et al, and U.S. Pat. No. 6,146,356, Wang et al,which describe balloons made from polyether-block-amide copolymers andpolyester-block-ether copolymers; U.S. Pat. No. 6,270,522, Simhambhatla,et al, describes balloons made from polyester-block-ether copolymers;U.S. Pat. No. 5,344,400, Kaneko, which describes balloons made frompolyarylene sulfide; U.S. Pat. No. 5,833,657, Reinhart et al, describesballoons having a layer of polyetheretherketone. All of these balloonsare produced from extruded tubing of the polymeric material by ablow-forming radial expansion process. U.S. Pat. No. 5,250,069,Nobuyoshi et al, U.S. Pat. No. 5,797,877, Hamilton et al, and U.S. Pat.No. 5,270,086, Hamlin, describe still further materials which may beused to make such balloons. Physical blends and copolymers of suchmaterials may also be used.

The balloon may be a laminate of two or more layers of the same ordifferent polymers or blends of polymers as described above. Moreoverthe two balloon portions 28 and 30 may be made of the same or differentpolymers, blends or laminates.

The first and second stents employed in the invention may be made fromany suitable biocompatible materials including one or more polymers, oneor more metals or combinations of polymer(s) and metal(s). Examples ofsuitable materials include biodegradable materials that are alsobiocompatible. Suitable biodegradable materials include polylactic acid,polyglycolic acid (PGA), collagen or other connective proteins ornatural materials, polycaprolactone, hylauronic acid, adhesive proteins,co-polymers of these materials as well as composites and combinationsthereof and combinations of other biodegradable polymers. Other polymersthat may be used include polyester and polycarbonate copolymers.Examples of suitable metals include, but are not limited to, stainlesssteel, titanium, tantalum, platinum, tungsten, gold and alloys of any ofthe above-mentioned metals. Examples of suitable alloys includeplatinum-iridium alloys, cobalt-chromium alloys including Elgiloy andPhynox, MP35N alloy and nickel-titanium alloys, for example, Nitinol. Atleast a portion of one or both stents may be provided with material orthickness that enhances the radiopacity of the stent.

One or both of the first and second stents employed in the invention maycarry one or more therapeutic agents which may be drugs or otherpharmaceutical products for release at the site of deployment. Thetherapeutic agent may be, for instance, an anti-thrombogenic agent,vascular cell growth promoter, growth factor inhibitors, antibiotics,DNA, RNA, proteins, polysaccharides, heparin, dexamethasone, Paclitaxel,Zotarolimus, Sirolimus (i.e. rapamycin), Everolimus, phosphorylcholine,17beta-estradiol, curcumin, malononitrilamide (e.g. malononitrilamideFK778), statins (e.g. fluvastatin), eptifibatide, irinotecan, triclosan,integrin-binding cyclic Arg-Gly-Asp peptide, cytochalasin D,mitoxantrone, carvedilol, alpha-1-antitrypsin (AAT), methotrexate,methylprednisolone, controlled release nitrogen oxide donor, tumornecrosis factor-alpha antibody, ciprofloxacin, Argatroban, angiopeptin,etc. The therapeutic agent may be carried in a coating, for instance apolystyrene-polyisobutylene-polystyrene triblock copolymer (SIBS),polyethylene oxide, silicone rubber and/or any other suitable coatingmaterial or it may be embedded or otherwise entrained in the stentstructure.

The stents may be created by methods including cutting or etching adesign from a tubular stock, from a flat sheet which is cut or etchedand which is subsequently rolled or from one or more interwoven wires orbraids. Any other suitable technique which is known in the art or whichis subsequently developed may also be used to manufacture the stentemployed in the invention.

In embodiments where the assembly comprises one or more therapeuticagents, an agent or agents on one part of the stent assembly may besimilar or different to the agent or agents which may be present onother parts. The dosage of the agents on a two-stent stent assembly mayvary or be different on different portions of the assembly.

The above examples and disclosure are intended to be illustrative andnot exhaustive. These examples and description will suggest manyvariations and alternatives to one of ordinary skill in this art. Allthese alternatives and variations are intended to be included within thescope of the claims, where the term “comprising” means “including, butnot limited to.” Those familiar with the art may recognize otherequivalents to the specific embodiments described herein whichequivalents are also intended to be encompassed by the claims. Further,the particular features presented in the dependent claims can becombined with each other in other manners within the scope of theinvention such that the invention should be recognized as alsospecifically directed to other embodiments having any other possiblecombination of the features of the dependent claims. For instance, forpurposes of claim publication, any dependent claim which follows shouldbe taken as alternatively written in a multiple dependent form from allclaims which possess all antecedents referenced in such dependent claimif such multiple dependent format is an accepted format within thejurisdiction. In jurisdictions where multiple dependent claim formatsare restricted, the following dependent claims should each be also takenas alternatively written in each singly dependent claim format whichcreates a dependency from an antecedent-possessing claim other than thespecific claim listed in such dependent claim.

1. An assembly comprising: a first stent having a longitudinal axis, atubular wall and a side branch opening, and a catheter assemblyextending through the side branch projection of the first stent, thecatheter assembly comprising: a catheter shaft, a balloon mounted on thecatheter shaft, the balloon having two adjacent independently inflatablechambers, the balloon having a proximal balloon portion that defines afirst of said chambers having a globular configuration when inflated,and a distal balloon portion that defines a second of said chambersdisposed distally of the first chamber, the second chamber having agenerally cylindrical configuration, and a second stent, the secondstent having a tubular body which includes a main body portion, and, aplurality of finger-like projections the second stent mounted over theballoon such that the finger like projections are disposed over aportion of the first chamber and the main body portion is disposed overthe second chamber, wherein the side branch opening in the first stentincludes a tubular projection extending at an angle to the longitudinalaxis from a portion of the tubular wall, the tubular projectionoverlapping with a portion of the second stent main body portion, andthe proximal balloon portion has a proximal end attached to the cathetershaft in everted form.
 2. An assembly as in claim 1 wherein the firstchamber of the balloon has a maximum perpendicular dimension (D1) takenin a plane perpendicular to the longitudinal axis of the balloon and anaxial length (D3) which is not more than about 20% greater than themaximum perpendicular dimension (D1).
 3. An assembly as in claim 2wherein, and the second chamber has a diameter (D2) which is less thanthe axial length (D3) of the first chamber.
 4. An assembly as in claim 2wherein the first chamber of the balloon has proximal and distal endsthe maximum perpendicular dimension (D1) occurs at a location betweenthe proximal and distal ends and the finger-like projections of thesecond stent extend over a portion of the first chamber from the distalend, but not beyond the location of the maximum perpendicular dimension.5. An assembly as in claim 1 wherein the tubular wall of the first stenthas a first stent diameter, and the first chamber of the balloon has anaxial length (D3) at nominal inflation that is in the range of 100-150%of the first stent diameter.
 6. An assembly as in claim 5 wherein thefirst chamber of the balloon has an axial length (D3) at nominalinflation that is in the range of 100-120% of the first stent diameter.7. An assembly as in claim 1 wherein the globular configuration of thefirst chamber of the balloon is generally spherical.
 8. An assembly asin claim 1 wherein at least the second chamber of the balloon isexpanded.
 9. An assembly as in claim 1 wherein the first and secondchambers of the balloon are expanded.
 10. An assembly as in claim 1wherein the first stent includes a frame opening interface between thetubular wall and the side branch projection and the finger-likeprojections of the second stent are bent around the frame intoengagement with the tubular wall of the first stent.